Page History

Description

Exposure (EX) is an interventions Interventions domain that contains used for the details of a subject's exposure to an investigational a study product. Exposure as Collected (EC) is an interventions domain that contains used for information about a subject's exposure to an investigational a study product, as collected. For collection, the EC domain is used to represent data as collected on the CRF, and is used in a study when the tabulation EX domain cannot be directly populated with the data collected on the CRF.

...

1. An alias for the actual product name is used rather than the actual product name.
2. Exposure data are collected in non-protocol-specified units.
3. Scheduled and/or missed exposures are collected.
4. Planned doses (e.g., a calculation based on body weight) exposures are collected in addition to actual doses givenexposures.

A sponsor An applicant may choose to always collect exposure data using the CDASHIG EC domain.Extensive discussion of the use of the EC and EX domains, including examples of data collection, is available in the SDTMIG. 

Specifications

...